Other Approaches and Sources
Another reason why the ECJ decision is likely to be less damaging to European stem cell research than commonly thought is because companies are also developing technologies that do not destroy hESCs. For example, Advanced Cell Technology’s (ACT) single blastomere platform can extract a single cell from a normal embryo for the purposes of generating an ESC line from that single cell,” Matthew Vincent, Ph.D., ACT’s director of business development, explained to GEN. “The embryo remains unharmed from the process and is refrozen. We do not change the fate of the embryo.”
Advanced Cell Technology says its ability to carry out the first hESC trial in Europe won’t be affected by the Court of Justice of the European Union’s decision, citing what it calls the court’s careful language. ACT has begun treating patients as part of a Phase I/II trial for Stargardt macular dystrophy using retinal pigment epithelium derived from hESCs.
Research on induced pluripotent stem cells (iPSCs) and adult stem cells is also unlikely to be affected by ECJ’s patenting ban for hESCs, MacLean said. While much research has indeed been done on iPSCs, more clinical work is needed to prove that they work.
Cytori Therapeutics said it could be among stem cell instrument companies helped by the ECJ decision. The company’s Celution® System family of medical devices and instruments extracts and separates stem and regenerative cells from an adult patient’s own adipose tissue rather than from human embryos.
“The decision is not going to have any impact on Cytori’s patents, because the ECJ ruling is clearly directed to embryonic stem cells,” Richa Nand, Cytori’s in-house counsel for intellectual property, told GEN. “We have other barriers to entry other than just patenting cells, and we focused on creating overlapping layers of patent protection. And I think that’s what other people in the field will have to really emphasize moving forward.” Cytori has separate patents for the Celution system device, single-use consumables, reagents, user interface, etc.
Cytori has won both initial and expanded indication approval in Europe for Celution, which is not yet available in the U.S. The expanded approval, received last year, covered new indications such as breast reconstruction, repair of soft tissue defects, as well as the facilitation of healing certain types of wounds such as those resulting from Crohn disease.
“We’re relatively close, we think, to getting approval for cardiac disease,” Cytori president Marc H. Hedrick, M.D., told GEN in August. “And we’re actually beginning to get reimbursement and are working toward our own diagnosis-related group payments for the technology in Europe.”